Canola Oil Multi-Centre Intervention Trial II
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Endocrine |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 20 - 65 |
| Updated: | 7/22/2018 |
| Start Date: | March 2013 |
| End Date: | November 2016 |
Effects of Oleic Acid Enriched and Regular Canola Oil on Body Composition and Lipid Metabolism in Participants With Metabolic Syndrome
The objectives of the study are to examine the health benefits of dietary canola oils on body
composition, specifically on android fat, and weight management. COMIT II will also include
analysis of FAEs to elucidate the mechanisms by which canola oil may be modifying body
composition. Measurement of endothelial function, inflammatory, adiposity, and insulin
sensitivity biomarkers will be done to determine the positive health impact of the changes in
body composition achieved through canola oil consumption.
composition, specifically on android fat, and weight management. COMIT II will also include
analysis of FAEs to elucidate the mechanisms by which canola oil may be modifying body
composition. Measurement of endothelial function, inflammatory, adiposity, and insulin
sensitivity biomarkers will be done to determine the positive health impact of the changes in
body composition achieved through canola oil consumption.
The proposed multi-center clinical trial would engage the same collaborative team that
successfully operationalized COMIT I, namely, the Richardson Centre for Functional Foods and
Nutraceuticals (RCFFN) at the University of Manitoba (Winnipeg, Manitoba, Canada), the
L'Institut Des Nutraceutiques et des Aliments Fonctionnels (INAF) at Laval University (Quebec
City, Quebec, Canada), the Department of Nutritional Sciences at The Pennsylvania State
University (University Park, Pennsylvania, USA), the Risk Factor Modification Centre at St.
Michael's Hospital (Toronto, Ontario, Canada). St. Boniface Hospital Research (Winnipeg,
Manitoba, Canada) will be an additional clinical trial site. The proposed COMIT II research
program will proceed as a double blind, randomized crossover study consisting of three
treatment phases of six weeks, each separated by a 6-week washout period. Participants will
consume a fixed composition of a precisely controlled basal, weight-maintaining diet (35%
energy from fat, 50% carbohydrate and 15% protein) supplemented with the following treatment
oils: (a) regular canola oil, (b) high stability/ high oleic canola oil and (c) a typical
"Western diet" fat intake as a control treatment comprised largely of saturated fat with
substantial levels of omega-6 linoleic acid, common to current North American intakes.
Treatment oils will be isocalorically incorporated into fruit smoothies made with milk and
consumed at breakfast and supper. The clinical segment of COMIT II is expected to be
completed by the mid to end of the second year, with sample analyses to be completed by the
end of year three.
successfully operationalized COMIT I, namely, the Richardson Centre for Functional Foods and
Nutraceuticals (RCFFN) at the University of Manitoba (Winnipeg, Manitoba, Canada), the
L'Institut Des Nutraceutiques et des Aliments Fonctionnels (INAF) at Laval University (Quebec
City, Quebec, Canada), the Department of Nutritional Sciences at The Pennsylvania State
University (University Park, Pennsylvania, USA), the Risk Factor Modification Centre at St.
Michael's Hospital (Toronto, Ontario, Canada). St. Boniface Hospital Research (Winnipeg,
Manitoba, Canada) will be an additional clinical trial site. The proposed COMIT II research
program will proceed as a double blind, randomized crossover study consisting of three
treatment phases of six weeks, each separated by a 6-week washout period. Participants will
consume a fixed composition of a precisely controlled basal, weight-maintaining diet (35%
energy from fat, 50% carbohydrate and 15% protein) supplemented with the following treatment
oils: (a) regular canola oil, (b) high stability/ high oleic canola oil and (c) a typical
"Western diet" fat intake as a control treatment comprised largely of saturated fat with
substantial levels of omega-6 linoleic acid, common to current North American intakes.
Treatment oils will be isocalorically incorporated into fruit smoothies made with milk and
consumed at breakfast and supper. The clinical segment of COMIT II is expected to be
completed by the mid to end of the second year, with sample analyses to be completed by the
end of year three.
Inclusion Criteria:
- Waist circumference ≥94 cm for men and ≥80 cm for women
Participants must meet at least one of the following secondary inclusion criteria:
- Fasting blood glucose of ≥ 5.6 mmol/L
- Triglycerides (TG) ≥1.7 mmol/L
- HDL cholesterol (HDL) <1 mmol/L (males) or <1.3 mmol/L (females)
- Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic).
Exclusion Criteria:
- Kidney, or liver disease, or unstable thyroid disease
- Diabetes mellitus
- Smokers
- Those consuming >1 alcoholic beverage a day for women and >2 for men.
- Any participant taking medication known to affect lipid metabolism or endothelial
function
We found this trial at
2
sites
University Park, Pennsylvania 16801
Principal Investigator: Penny Kris-Etherton, PhD
Phone: 814-863-2923
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